At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
OVERVIEW: Main Purpose and Objectives of Position:
The Senior Director Quality is directly responsible for providing technical understanding and communication (to multiple functions and organizational levels) regarding the execution of the quality management system (QMS). The QMS will be flexible in nature to allow for all production activities from Product Research and Development (PR&D) through Commercial operations including cell/virus banking, drug substance, drug product and final shipping controls. The LP2 site will be the first Lilly manufacturing facility operating within the ATMP framework. The individual in this role must effectively influence leadership on the strategic direction and tactical implementation of the quality system. The individual in this role establishes the site's quality objectives, priorities, and roadmap.
The QA Senior Director leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This includes delivery and commercialization of the LP2 facility.
The individual in this role has supervisory responsibilities providing both administrative and technical leadership to the site. This includes serving as the Site Quality Leader for LP2. This individual oversees daily work and provides direction on key priorities as needed. They provide leadership and direction in managing product-related quality matters, assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with US and international regulatory requirements.
The QA Senior Director leads and responds to regulatory agency inspections and inquiries. They review/approve GMP documentation including procedures, training, master production records, technical protocols/reports, change proposals, deviations, and corrective/preventive actions.
In the project delivery phase and startup phase of the project (startup expected 2025/2026), the Site Lead Team roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
Key Responsibilities for this role include:
Pre-Startup and Startup Phase:- Be a collaborative, inclusive, energetic leader and support the broader lead team to:
- Develop the LP2 site organization with the necessary capability, capacity and culture to operate this facility to the highest standards of safety, quality, and operational excellence.
- Develop and implement the quality systems and processes needed to run the site, leveraging existing Lilly knowledge where necessary, but also incorporating external experiences and learning.
- Develop people capability & knowledge (technical expertise, behavioral & managerial). Specially grow knowledge of ATMPs (e.g., gene therapies).
- Establish lean practices and a continuous improvement mindset throughout operations and the direct supporting organizations.
- Support the project team to deliver the facility to you as the end user, by providing feedback and support on design decisions, commissioning strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer term strategic goals for the site.
Post Startup:- Develop the strategic and operational plans for Quality and be responsible for the execution of these plans in his/her areas of direct responsibility.
- Participate in development and delivery of the medium and long term strategic direction for the site.
- Ensure effective Quality oversight to ensure compliance with all applicable regulatory requirements.
Quality Compliance:
- Assures the independence of the Site Quality Unit.
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Ensures the development, adequacy, and effectiveness of the site's quality management system.
- Ensures systems are in place to release or reject raw materials, intermediates, packaging materials, device components, and consumables.
- Establish and ensure a system is in place for evaluating and releasing batch records in accordance with regulations and company standards.
- Ensure all necessary controls, testing, and monitoring are carried out with the quality control function in accordance with the marketing authorization.
- Ensure a system is in place for approving specification, sampling instructions, test methods & batch records.
- Ensure that all required quality agreements are in place and maintained.
- Ensure site processes, equipment, instruments, utilities & facilities are qualified / validated and maintained for the intended use.
- Approve Annual Product Reviews.
- Ensure site inspection readiness. Host audits and inspections. Assure timely closure of all regulatory commitments.
- Assure the adequacy and effectiveness of the site quality systems.
- Participate on the Site Lead Team and lead the Quality Lead Team.
- Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and regulatory requirements through review and approval of GMP documentation.
- Ensure the site has a process to maintain compliance status through gap assessment of corporate and regulatory standards and guidelines.
- Ensure adequate quality oversight on GMP documents and activities (e.g., through QA presence on the shop floor).
- Support the development of the overall site operational readiness plan.
- Coordinate site regulatory strategy with the global regulatory group.
- Coordinate the creation and execution of the site Quality Plan.
- Plan and execute the site self-assessment program.
- Ensure data integrity by design
Basic Requirements:
- Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
- 10+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group
Additional Skills/ Preferences- Drug Substance or Drug Product manufacturing of advanced therapies (Biotech, Cell and/or Gene Therapy) is preferred.
- Must possess knowledge and understanding of cGMPs and how they apply to manufacturing operations.
- Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, ATMP)
- Previous experience directly supporting pharmaceutical operations (e.g., drug substance, parenteral drug product), preference for support with cell or gene therapy
- Previous cGMP regulatory inspection readiness and inspection execution experience
- Previous facility or area start up experience, including equipment and process validation support
- Must have a strong ability to form effective relationships at all levels. This candidate must be able to work closely with the Site Leadership team to ensure alignment with corporate objectives and internal decision making processes, and be able to connect and communicate effectively with all levels of the organization on site.
- Should have a demonstrated track record of successfully developing, managing and executing projects from start to finish on time and within budget with high performance standards that ensure customer satisfaction.
- Should have experience developing and managing extremely talented, engaged and high performing teams with a focus on building strong team cultures to ensure a safe and successful work environment.
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